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FDA 510(k)

HALIFAX BIOMEDICAL TANATLUM BEAD SET

K-Number: K103417 · 2011-06-28

ApplicantHalifax Biomedical, Inc.
Decision Date2011-06-28
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HALIFAX BIOMEDICAL TANATLUM BEAD SET is the device name listed in this FDA 510(k) record. The listed applicant is Halifax Biomedical, Inc.. It received FDA 510(k) clearance on 2011-06-28 under 510(k) number K103417. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HALIFAX BIOMEDICAL TANATLUM BEAD SET?

HALIFAX BIOMEDICAL TANATLUM BEAD SET is a medical device that received FDA 510(k) clearance on 2011-06-28. The listed applicant is Halifax Biomedical, Inc.. The 510(k) number is K103417.

When did HALIFAX BIOMEDICAL TANATLUM BEAD SET receive FDA 510(k) clearance?

HALIFAX BIOMEDICAL TANATLUM BEAD SET received FDA 510(k) clearance on 2011-06-28, under 510(k) number K103417.

Who is the listed applicant for HALIFAX BIOMEDICAL TANATLUM BEAD SET?

The FDA 510(k) record lists Halifax Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALIFAX BIOMEDICAL TANATLUM BEAD SET?

The FDA product code for HALIFAX BIOMEDICAL TANATLUM BEAD SET is NEU.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Halifax Biomedical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182880Halifax Imaging KitK121345SR SUITE 1.0K090581TANTALUM BEAD SET, MODEL P003175

Related Devices (Code: NEU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)Devicor Medical Products, Inc.K253888MOLLI 2 SystemStryker EndoscopyK252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc.K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ Breast Tissue MarkerBard Peripheral Vascular, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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